Recall of Device Recall Medtronic Everest Disposable Inflation Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Balloon Inflation Syringe - Product Code MAV
  • Reason
    Product sterility may be compromised due to breach of package seal integrity.
  • Action
    Medtronic issued a Urgent Medical Device Recall Notice to US customer on 7/15/2010 and to foreign accounts advising of the issue and requesting that they segregate recalled product. A Medtronic Sales Rep will visit their facility to account for all affected product and initiate a credit. Foreign accounts will return product to their respective distribution centers.


  • Model / Serial
    Lot numbers: 50517330, 50517331,50517332, 50517333, 50517334, 50519716, 50519717, 50519718, and 50519679.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- USA, including the state of MI and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom.
  • Product Description
    Medtronic¿ Everest¿ 20 Disposable Inflation Device, AC2200. || Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.
  • Manufacturer


  • Manufacturer Address
    Medtronic, Inc., 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • Source